MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151


Device Classification Name

stylet, catheter

510(k) Number K080924
Device Name MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151
Applicant
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
15900 valley view ct.
sylmar, 
CA 
91342

Applicant Contact colleen canan
Correspondent
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
15900 valley view ct.
sylmar, 
CA 
91342

Correspodent Contact colleen canan
Regulation Number 870.1380
Classification Product Code
DRB  
Date Received 04/02/2008
Decision Date 04/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No